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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00383994 |
Purpose
The goal of this clinical research study is to find out if giving a boost of natural killer (NK) cells from a donor, combined with Rituxan (rituximab), can help to control disease in patients who have already received an allogeneic stem cell transplant. The safety of this treatment will also be studied.
Primary Objectives:
1.0 To determine the safety of Natural Killer (NK) cells and Rituximab + rhu-GMCSF in patients with persistent or recurrent B-cell lymphoid malignancies after non-myeloablative stem cell transplantation.
2.0 To determine factors associated with response.
| Condition | Intervention |
|---|---|
|
Lymphoma Leukemia Stem Cell Transplantation |
Drug: GM-CSF Drug: Rituximab Biological: NK Cell Infusion |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Immunotherapy With NK Cell, Rituximab and Rhu-GMCSF in Non-Myeloablative Allogeneic Stem Cell Transplantation |
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2006 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Immunotherapy with NK Cell, Rituximab + GM-CSF
Immunotherapy in Non-myeloablative Allogeneic Stem Cell Transplantation GM-CSF = Granulocyte-Macrophage Colony-Stimulating Factor |
Drug: GM-CSF
250 micrograms subcutaneously 3 times a week for 4 weeks starting a day before the administration of Rituximab.
Other Names:
Drug: Rituximab
375 mg/m^2 by vein followed by 1000 mg/m^2 weekly for 3 weeks for a total of 4 doses.
Other Name: Rituxan
Biological: NK Cell Infusion
NK cells will be infused one week after the fourth dose of Rituximab and GM-CSF.
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Rituximab is designed to attach to lymphoma cells, causing them to die. GM-CSF and NK cells may increase rituximab's ability to kill these cells.
Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have your complete medical history recorded and a physical exam. Your blood (about 2 tablespoons) will be collected for routine tests. A bone marrow aspirate will be performed. To collect a bone marrow aspirate, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle. You will have computerized tomography (CT) scans as well as positron emission tomography (PET) or gallium scans to learn the status of your disease. Women who are able to have children must have a negative blood or urine pregnancy test.
If you are found eligible to take part in this study, you will receive treatment as an outpatient. You will receive GM-CSF 3 times a week for 4 weeks through a vein, starting the day before you receive the administration of rituximab. You will receive rituximab over 4 to 8 hours through a vein, once weekly for 4 weeks. You will also get a boost of NK cells from the same donor from whom you received your original transplant. These cells will be infused through a vein (over 30 to 60 minutes) after the 4th dose of rituximab. If you are receiving a cell infusion from somebody who you are not related to, the infusion may have to be done later if cells were not available as scheduled.
The CliniMACS System is a medical device that is used to separate types of blood cells from blood that is removed from the body during leukapheresis. These separated cells are processed for use in treatments such as stem cell transplants.
During this treatment, you will be examined as needed, and blood samples (1 tablespoon once or twice a week) will be taken for routine tests. You may need to receive blood transfusions during this study if your blood cell counts remain low.
You may be taken off this study if your disease gets worse or intolerable side effects occur.
You will have long-term, follow-up visits while on study. You will be seen at 4 to 6 weeks after you receive NK cell infusion; every 3 months during the first year; and then once a year. During each of these visits, you will have CT and PET scans, a bone marrow biopsy, and blood drawn (about 4 teaspoons) to learn the status of your disease.
This is an investigational study. Rituximab and GM-CSF are FDA approved and commercially available. NK cells are authorized by the FDA for use in research only. Up to 40 participants will take part in this study. All will be enrolled at M. D. Anderson.
The CliniMACS device is not FDA approved. At this time, it is being used in research only.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Issa F. Khouri, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00383994 History of Changes |
| Other Study ID Numbers: | 2005-0234 |
| Study First Received: | October 2, 2006 |
| Last Updated: | September 1, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Chronic Lymphocytic Leukemia CLL Non-Hodgkin's Lymphoma B-Cell Lymphoma Lymphoma Leukemia |
NK Cells Rituximab GM-CSF Non-myeloablative Allogeneic Stem Cell Transplantation Stem Cell Transplant |
|
Leukemia Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
